Comparative Pharmacokinetics and Safety of TNX-102 SL Tablets and Cyclobenzaprine Oral Tablet in Healthy Adults
|ClinicalTrials.gov Identifier: NCT01689259|
Recruitment Status : Completed
First Posted : September 21, 2012
Last Update Posted : September 26, 2014
|Condition or disease||Intervention/treatment||Phase|
|Healthy Adults||Drug: SL TNX-102 at 2.4 mg Drug: SL TNX-102 at 4.8 mg Drug: SL TNX-102-A at 2.4 mg Drug: Cyclobenzaprine tablets||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-Dose, Open-Label, Randomized, Parallel-Design Study of the Comparative Pharmacokinetics and Safety of TNX-102 2.4 mg SL Tablets (With Phosphate) at 2.4 mg and 4.8 mg, TNX-102-A 2.4 mg SL Tablets (Without Phosphate) at 2.4 mg and Cyclobenzaprine 5 mg Oral Tablets in Healthy Adults.|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||March 2014|
Experimental: SL TNX-102 at 2.4 mg
1 x TNX-102 SL Tablets at 2.4 mg
Drug: SL TNX-102 at 2.4 mg
1 TNX-102 SL Tablet at 2.4 mg held under the tongue until dissolution, without swallowing or chewing it.
Experimental: SL TNX-102 at 4.8 mg
2 x TNX-102 SL Tablets at 2.4 mg
Drug: SL TNX-102 at 4.8 mg
2 TNX-102 SL Tablet at 2.4 mg held under the tongue until dissolution, without swallowing or chewing them.
Experimental: SL TNX-102-A at 2.4 mg
1 x TNX-102-A (without phosphate) SL Tablet at 2.4 mg
Drug: SL TNX-102-A at 2.4 mg
1 TNX-102-A SL Tablet at 2.4 mg held under the tongue until dissolution, without swallowing or chewing it.
Active Comparator: Cyclobenzaprine tablets
1 x 5 mg cyclobenzaprine oral tablet
Drug: Cyclobenzaprine tablets
1 x 5 mg cyclobenzaprine tablet, swallowed with 240 mL of room-temperature water
- Measured levels of cyclobenzaprine and norcyclobenzaprine in plasma and urine [ Time Frame: 27 time points per period for blood assessment ; 3 pooled analyses in urine. ]Blood samples will be taken per period: within 30 minutes pre-dose and 2, 3.5, 5, 10, 20, 30, and 45 minutes and 1, 2, 2.5, 3, 3.33, 3.67, 4, 4.33, 4.67, 5, 5.5, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose. A single urine sample will be collected within 30 minutes pre-dose (one sample), and urine will be pooled from 0-24, 24-48 and 48-72 hours post-dose.
- Safety and tolerability of TNX-102 SL Tablets at 2.4 mg and 4.8 mg. [ Time Frame: Continuously until the end (day 4) of the study period + Telephone follow-up 7-13 days after dosing (total duration: about 1 month) ]Every adverse events occurring during the study period will be reported.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01689259
|Quebec City, Quebec, Canada, G1P 0A2|
|Study Chair:||Seth M. Lederman, MD||Tonix Pharmaceuticals, Inc.|
|Study Director:||Jeffrey P. Kitrelle, MD||Tonix Pharmaceuticals, Inc.|
|Principal Investigator:||Denis Audet, MD||PharmaNet|